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NCT02246855 Clinical Trial

A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers

Healthy Clinical Trial

Official title:
A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg (Vigam® Liquid and Gammaplex®) Using Standard and Accelerated Infusion Rates in Healthy Adult Volunteers (Three Treatment Arms)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02246855
Other study ID # GMX03
Secondary ID
Status Completed
Phase Phase 1
First received September 2, 2014
Last updated February 26, 2018
Start date August 2004

Study information
Verified date August 2014
Source Bio Products Laboratory
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main object of the study is to compare the AUC0-84, of a single intravenous infusion of Vigam® Liquid (infused at the licensed rate of up to 3mL/min) with Gammaplex® (infused at up to 3mL/min and up to 6mL/min).

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date December 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Healthy, normotensive, non-smoking male and female volunteers aged 18 to 60 who gave written informed consent and fulfilled all of the inclusion criteria and none of the exclusion criteria.

- Female volunteers of childbearing potential had a negative pregnancy test before entering the study and had to use either a double barrier method of contraception or use the oral contraceptive pill.

- Postmenopausal or surgically sterile female volunteers could be enrolled.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Gammaplex® (Human Normal Immunoglobulin)

Locations
Country Name City State
United Kingdom Clinical Pharmacology Research Unit (CPRU) Level 7, Northwick Park Hospital Watford Road, Harrow

Sponsors (1)
Lead Sponsor Collaborator
Bio Products Laboratory

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary PK parameters for serum immunoglobulin G (IgG) Screening, pre-dose (Day 1), 15 min, 4 hr, 24 hr, 30 hr, 48 hr, Days 4, 8, 11, 15, 18, 22, 29, 36, 43, 50, 57, 71, 85
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